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临床试验/NCT04692298
NCT04692298已完成不适用

Pulse Consumption Improves Gut Health, Metabolic Outcomes, and Bone Biomarkers of Postmenopausal Women

Oklahoma State University2 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2021年2月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
41
试验地点
2
主要终点
blood C-terminal telopeptide of type 1 collagen (CTX)

研究概览

简要总结

This study will investigate the effects of the addition of 100 grams/day of cooked pulses (i.e. lentil, pinto beans, peas, chickpeas, kidney beans) to the diet of postmenopausal women for 12 weeks on gut health, metabolic outcomes and bone biomarkers.

详细描述

With approximately 1.3 million women reaching menopause each year in the US and about one-third of a woman's life is spent in this state, it is imperative to identify effective, safe, and economical approaches that can minimize disease risk that is associated with this phase of life. Pulses are excellent source of fiber, protein, essential amino acids, vitamins, minerals and phytochemicals, that can act as prebiotics and prevent gut dysbiosis and promote a healthy gut. A few studies in overweight or obese adults have shown the health benefits of pulses, including gut modulating potential. However, studies examining the use of pulse crops are limited, especially in alleviating health risks associated with menopause. The objective of this study is to evaluate the prebiotic potential of pulse-based diet and consequent effects on metabolic and bone biomarkers in postmenopausal women. We hypothesize that daily intake of pulses, due to its nutrient content and many other bioactive compounds including fiber content, will beneficially affect gut health and subsequently improve metabolic outcomes and bone markers in postmenopausal women. To accomplish our objectives, 40 postmenopausal women (50- 65 y old and ≥ 1 y menopause) will be recruited and will be asked to consume 100 g/d of pulse (alternate between lentils, pinto beans, peas, chickpeas, and kidney beans) for 3 months. Pulse intake, anthropometric measures, markers of gut and bone health, and metabolic outcomes will be assessed at baseline and at the end of pulse consumption.

Once the study was underway and we got more funding, women were given the option to continue pulse supplementation for another six months to examine changes on bone density.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
45 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 1 year without menstrual cycle

排除标准

  • any medication use (for the past 6 m) that affects glucose, lipids, bone and inflammation markers, dietary supplements, and non-steroidal anti-inflammatory medications
  • allergy to pulse crops
  • tobacco use
  • excessive alcohol intake
  • antibiotic use
  • major surgery within 6 m of study enrollment

结局指标

主要结局

blood C-terminal telopeptide of type 1 collagen (CTX)

时间窗: change from baseline after 90 days

analyzed by enzyme-linked immunoassay

fecal short chain fatty acid

时间窗: change from baseline after 90 days

analyzed by gas chromatography

blood procollagen type 1 N-propeptide (P1NP)

时间窗: change from baseline after 90 days

analyzed by enzyme-linked immunoassay

fecal immunoglobulin A

时间窗: change from baseline after 90 days

analyzed by enzyme-linked immunoassay

changes in blood biomarkers and/or bone mineral density (BMD)

时间窗: change from baseline, after 90 days and 9 months (for BMD)

analyzed by enzyme linked immunoassay or dual energy xray absorptiometry for BMD

fecal bacteria

时间窗: change from baseline after 90 days

analyzed by 16sRNA sequencing

plasma concentrations of fatty acid binding protein

时间窗: change from baseline after 90 days

analyzed by enzyme-linked immunoassay

次要结局

  • blood triglycerides(change from baseline after 90 days)
  • fasting blood glucose(change from baseline after 90 days)
  • blood insulin(change from baseline after 90 days)
  • blood C-peptide(change from baseline after 90 days)
  • blood glycosylated hemoglobin(change from baseline after 90 days)
  • blood total cholesterol(change from baseline after 90 days)
  • blood LDL cholesterol(change from baseline after 90 days)
  • blood HDL cholesterol(change from baseline after 90 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Edralin Lucas

Jim an Lynn Williams Professor

Oklahoma State University

研究点 (2)

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